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Sunday, July 24. 2011

The U.S. Food and Drug Administration (FDA) is hoping to extend its regulatory fiefdom to mobile medical applications. The agency released its draft guidelines on July 19, 2011 and will accept comments until October 19th.

The FDA portrays the guidelines as uncontroversial. "These are the devices we have been regulating all along and just because they are on a mobile platform doesn’t mean we should be regulating differently,” the FDA's Dr. Jeffrey Shuren told MobiHealthNews. It's telling that the FDA doesn't cite examples of anyone being harmed.

However, the FDA’s argument that it is merely being consistent can also be used against the proposed guidelines. As the same article in MobiHealthNews pointed out, in 1989 the FDA proposed guidelines for regulating PC-based products but was forced to abandon the effort when the number and variety of such products quickly mushroomed.

The FDA also downplays the guidelines’ significance by pointing out that only a small percentage of mobile health apps would be affected. To wit, the guidelines only apply to apps that are used to diagnose and treat medical conditions. These include mobile apps that work with already regulated medical devices, mobile apps that turn handhelds into medical devices, and mobile apps that issue recommendations about a patient’s diagnosis or treatment.

The FDA's Bakul Patel commented, "We are starting off with the very small tip of the pyramid"—implying that we should be grateful that fitness and wellness applications are not included. He offered the hypothetical example of an app that transforms an iPhone into a stethoscope. Since stethoscopes are regulated, apps that turn iPhones into stethoscopes should also be regulated.

I challenge the wisdom of regulating stethoscopes in the first place. If physicians aren’t smart enough to purchase decent quality stethoscopes, then they probably aren’t smart enough to use them properly. Besides, I see no evidence that the FDA is smarter than most physicians, and the risks associated with regulating stethoscopes are arguably as great as the risks associated with not regulating them.

Patel explained the FDA is focusing on new risks posed by mobile platforms including small screen size, lower contrast ratio, uncontrolled ambient light, and use of the apps by ordinary consumers. However, all products have limitations, and the idea that a government agency can somehow eliminate them creates a dangerous illusion. Besides, these limitations are rather obvious. I would rather that physicians and consumers be mindful of the limitations than be denied affordable and timely products.

Instead of scheming to establish new regulations, the FDA would be wiser to take the opportunity afforded by mobile medical apps to test a completely different approach. The FDA could better serve the public by testing and reviewing mobile medical apps while subscribing to the highest standards of objectivity. This would enable the FDA to earn immense credibility while permitting physicians and consumers to make their own choices. I would hate to see this exciting new industry handcuffed by burdensome regulations.

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